AccessGUDID - DEVICE: Burn Navigator (B2551120)

GUDID

Device Identifier (DI) Information

Brand Name: Burn Navigator
Version or Model: H2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1120
Company Name: ARCOS, INC.

Primary DI Number: B2551120
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 831782672 *Terms of Use

Device Description: Burn Navigator H2 model

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60702	Clinical information system web-based application software	An application software program designed as an Internet-based information system to support the administrative, clinical, and quality control activities associated with the provision/utilization of healthcare within a specific clinical specialty (e.g., orthopaedics, general surgery, neurology, ophthalmology, oncology, rheumatology, dermatology). It can be available on any web-enabled interface (including mobile devices at point-of-care) and is intended for use by healthcare professionals in a clinical setting.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
PDT	Burn Resuscitation Decision Support Software

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121659	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4b191818-2bc0-42b2-85e2-c5bfcc4cb204
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 26, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 877-542-8025
Email: support@arcosmedical.com

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